510(k) · Cleared
ClearedHorizon Xvu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mennen Medical, Ltd. · DQK Computer, Diagnostic, Programmable
Cleared on Aug 7, 2009 as substantially equivalent to K081484 (Mennen Medical, Ltd., 2008) and 1 other predicate after a 107-day review. Its family tree reaches back 4 generations to 1986.
- Decided
- Aug 7, 2009
- Review
- 107 days
- Class
- Class II
- Product code
- DQK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K862740 (1986). 14 ancestors in all, the oldest K854196 (1986). No later device cites it as a predicate yet.
- Root · 4 generations backK862740 Quinton Q.CathQuinton, Inc. · 1986
- 3 generations backK971570 Epxpress System (Timberwolf Revision) /000391Quinton Electrophysiology Corp. · 1997
- 2 generations backK993414 Prucka Engineering Inc. Cardiolab EP System,Version 4.2Prucka Engineering, Inc. · 2000
- 1 generation backK071348 Ems-XL Cardiac Electrophysiology SystemMennen Medical, Ltd. · 2007
- This deviceK091165 Horizon XvuMennen Medical, Ltd. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K862740 | Quinton Q.Cath | Quinton, Inc. | 1986 | — |
| −3 | K971570 | Epxpress System (Timberwolf Revision) /000391 | Quinton Electrophysiology Corp. | 1997 | — |
| −2 | K993414 | Prucka Engineering Inc. Cardiolab EP System,Version 4.2 | Prucka Engineering, Inc. | 2000 | — |
| −1 | K071348 | Ems-XL Cardiac Electrophysiology System | Mennen Medical, Ltd. | 2007 | — |
| 0 (this device) | K091165 | Horizon Xvu | Mennen Medical, Ltd. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 3 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DQK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DQK device
- #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.7 · 28 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081484 | Horizon XvuSummary page 1…addition ofintra Cardiac ECG (ICECG) measurement. This submission is for a modification ofthe Horizon XVu that Mennen Medical has received 510OK clearance for marketing K081484 (see attached FDA approvals in part 2 1) We intend to add to the Horizon XVu Computerized Catheterization Laboratory, ICECG meas… | 2008 |
| * | K071348 | Ems-XL Cardiac Electrophysiology SystemSummary page 1…zed Catheterization Laboratory, ICECG measurement option usingas a predicated device the ICECG measurement of the Mennen Medical EMS-XL cardiac electrvphysiology system (K07 1348). (See attached FDA letter Part 21) Horizon XVu = The predicate device. The Horizon XVu Cathlab was cleared for marketing by the… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 4 companies; a new generation was cleared every 7.4 years on median.
- None of the 14 ancestors has a recall.
How does its category compare?
All DQK devicesDQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQK
23so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · DQK
95in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQK
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQK
433in 2025
MAUDE reports naming product code DQK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 13 | 83 | 4 | 18 |
| 2008 | 4 | 70 | 1 | 34 |
| 2009 | 12 | 93 | 2 | 40 |
| 2010 | 9 | 64 | 3 | 49 |
| 2011 | 12 | 69 | 2 | 55 |
| 2012 | 7 | 74 | 3 | 129 |
| 2013 | 13 | 68 | 1 | 180 |
| 2014 | 9 | 90 | 4 | 115 |
| 2015 | 7 | 125 | 2 | 131 |
| 2016 | 15 | 190 | 0 | 340 |
| 2017 | 7 | 146 | 2 | 252 |
| 2018 | 14 | 150 | 6 | 261 |
| 2019 | 15 | 113 | 1 | 218 |
| 2020 | 16 | 123 | 1 | 215 |
| 2021 | 16 | 132 | 1 | 351 |
| 2022 | 19 | 136 | 2 | 319 |
| 2023 | 21 | 133 | 2 | 340 |
| 2024 | 13 | 100 | 24 | 557 |
| 2025 | 22 | 95 | 1 | 433 |
| 2026 | 23 | 151 | 2 | — |
What is it indicated for?
The Horizon XVu is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, Intra Cardiac ECG (ICECG), invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures and EtCO2.
Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, can be stored, recorded, analyzed and presented in a variety of report formats.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091165 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091165: Horizon Xvu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091165
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026